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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K926353
Device Name FLOWGEL(R) TOPICAL WOUND DRESSING
Applicant
Mediventures, Inc.
15250 Mercantile Dr.
Dearborn,  MI  48120
Applicant Contact LUANN ERLICH
Correspondent
Mediventures, Inc.
15250 Mercantile Dr.
Dearborn,  MI  48120
Correspondent Contact LUANN ERLICH
Classification Product Code
MGQ  
Date Received12/21/1992
Decision Date 02/22/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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